Only medicines that are used for the treatment of serious or life-threatening conditions are eligible for priority review. The first step is for the sponsor to apply for the priority review pathway.
There are a number of eligibility criteria for the priority review pathway. Most importantly:
The medicine must be a new treatment for a serious or life-threatening condition.
Substantial research evidence must show that the medicine provides a significant benefit compared to existing treatments at the time of application.
Some of the medicines we have approved through the priority review pathway are used in the treatment of conditions such as prostate cancer and specific types of lung cancer, skin cancer, and haemophilia.
Research and evidence for medicines approved through priority review
Priority medicines are approved on the basis of the same amount of research (evidence) as we would normally require for the approval of a prescription medicine.
Some priority medicines may have a black triangle symbol in the Consumer Medicines Information (CMI) or Product Information (PI). This does not mean that there are known safety problems with the medicine. The black triangle symbol means that we are encouraging side effects to be reported to help us build up the full picture of the medicine’s safety profile. More information on the Black Triangle Scheme is available on our website.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.